MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Dyskinesia (2363); Convulsion/Seizure (4406)

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Zhang, x., fang, x., gao, a., guan, d., guo, c., wang, s., chen, y., zhao, b., yang, k., hu, e., liang, h., hu, f.Safety analysis of simultaneous cranioplasty and ventriculoperitoneal shunt placement.Turk neurosurg.32(2):195-203.Doi: 10.5137/1019-5149.Jtn.30740-20.2 aim: to investigate the safety of combined cranioplasty (cp) and ventriculoperitoneal shunt (vps) placement.Furthermore, we investigated whether the sequence of these procedures affects the postoperative complication rates associated with staged cp andvps placement.Material and methods: we retrospectively investigated patients who developed communicating hydrocephalus after decompressive craniectomy and subsequently underwent vps placement and cp at the hospital at which this study was performed between january 2009 and december 2019.Patients were categorized into group 1 (simultaneous cp and vps placement) and group 2 (cp and vps placement performed separately).Group 2 was subcategorized into subgroup 2a (cp performed before vps placement) and subgroup 2b (vps placement performed before cp).The student¿s t and chi square tests were used to analyze intergroup differences.Results: this study included 86 patients; 22 in group 1 and 64 in group 2 (24 patients in subgroup 2a and 40 patients in subgroup 2b).No statistically significant difference was observed in the overall complication rates between groups 1 and 2 (36.4% vs.28.1%, p=0.591).However, the incidence of infections was significantly higher in group 1 than in group 2 (22.7% vs.4.7%, p=0.024).Subgroup analysis showed that the overall complication rate was significantly lower in subgroup 2a than in subgroup 2b (12.5% vs.37.5%, p=0.031).Conclusion: simultaneous cp and vps placement is associated with a high incidence of infections.Moreover, compared with initial cp, initial vps placement is associated with a significantly higher risk of overall complications in patients who undergo a staged procedure.Reportable events: 8 patients (5 in group 1, 3 in group 2) got an infection 3 patients in group 2 had an obstruction 3 patients (1 in group 1, 2 in group 2) had a seizure 3 patients in group 2 had an epidural hemorrhage 8 patients (3 in group 1, 5 in group 2) had an epidural hygroma 6 patient in group 2 had sinking skin flap syndrome (ssfs)/paradoxical herniation.

• Brand Name: DELTA®
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14253011
• MDR Text Key: 290458010
• Report Number: 2021898-2022-00112
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K902783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN-A
• Device Catalogue Number: UNKNOWN-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male